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Belegg for å optimalisere aneurismebehandling i den nye generasjonen av strømningsavleder (COATING)

15. september 2026 oppdatert av: Phenox GmbH

To assess safety and efficacy of p64 MW HPC Flow Modulation Device under single antiplatelet therapy compared to p64 MW Flow Modulation Device under dual antiplatelet therapy.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

171

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Frankrike
      • Bordeaux, Frankrike, 33076
        • CHU Bordeaux
      • Le Kremlin-Bicêtre, Frankrike, 94270
        • Hôpital Bicêtre
      • Lyon, Frankrike, 69002
        • CHU de Lyon
      • Montpellier, Frankrike, 34090
        • CHU de Montpellier
      • Reims, Frankrike, 51092
        • CHU Reims - Hôpital Maison Blanche
  • Israel
      • Jerusalem, Israel, 9112001
        • Hadassah University Medical Center
  • Italia
      • Milan, Italia, 20133
        • Fondazione I.R.C.C.S. Instituto Neurologico Carlo Besta
  • Slovakia
      • Košice, Slovakia, 04190
        • UNLP Košice
  • Storbritannia
      • Birmingham, Storbritannia, B15 2GW
        • Queen Elisabeth Hospital Birmingham
      • Edinburgh, Storbritannia
        • Western General Hospital
  • Sveits
      • Basel, Sveits, 4051
        • Universitätsspital Basel
  • Tyskland
      • Augsburg, Tyskland, 86156
        • Universitätsklinikum Augsburg
      • Erfurt, Tyskland, 99089
        • Helios Klinikum Erfurt
      • Halle, Tyskland, 06120
        • Universitätsklinikum Halle (Saale)
      • München, Tyskland, 81377
        • Klinikum der LMU München
      • Nuremberg, Tyskland, 90471
        • Klinikum Nürnberg Süd
      • Recklinghausen, Tyskland
        • Klinikum Vest Recklinghausen
      • Stuttgart, Tyskland, 70174
        • Klinikum Stuttgart

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. At least 18 years of age.
  2. Subject has a saccular, unruptured or recanalized intracranial aneurysm. The subject may also have a previous ruptured aneurysm, provided rupture of this aneurysm 30 days from the index procedure.
  3. Subject is intended to be treated for only one target aneurysm during the index procedure except for segmental disease (multiple aneurysms located on the same arterial segment aimed to be treated with one investigational device or investigational telescopic devices).
  4. Subject has already been selected for flow diversion therapy as the appropriate treatment.
  5. Subject has a mRS ≤ 2 before the procedure, as determined by a certified assessor independent of the index procedure.
  6. Subject is able to understand the patient information and provides written informed consent verifying the use of his/her data (according to data protection laws).

Exclusion Criteria:

  1. Subject who is currently prescribed under any long lasting antiplatelet and/or anticoagulation medication.
  2. Subject has undergone a surgery including endovascular procedures in the last 30 days prior to the study procedure.
  3. Subject has had an Intracranial hemorrhage and/or subarachnoid hemorrhage in the past 30 days prior to the study procedure.
  4. Subject with target aneurysm previously treated with a stent or flow diverter.
  5. Subject is expected to be treated for another aneurysm during the 30 days following the index procedure.
  6. Subject with a confirmed stenosis in parent artery.
  7. Subject with a blister-like aneurysm, fusiform aneurysm, dissecting aneurysm or aneurysm associated with a brain arteriovenous malformation (AVM).
  8. Subject has a pre-procedure mRS >2.
  9. Any known contraindication to treatment with the p64 MW HPC Flow Modulation Device in accordance with device IFU.
  10. Subject who has undergone stenting of the ipsilateral carotid artery within 3 months of the index procedure.
  11. Known serious sensitivity to radiographic contrast agents.
  12. Known sensitivity to nickel, titanium metals, or their alloys.
  13. Subject already enrolled in other clinical trials (including COATING study) that would interfere with study endpoints.
  14. Known renal failure as defined by a serum creatinine > 2.5 mg/dl (or 220 μmol/l) or glomerular filtration rate (GFR) < 30.
  15. Subject who has a contraindication to MRI or angiography for whatever reason.
  16. Subject with a comorbid disease or condition that would confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments.
  17. Subject with any known allergy to heparin, ASA or other antiplatelet medications.
  18. Subject with coagulation disorder
  19. Pregnant woman or breast feeding.
  20. Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: p64 MW HPC Flow Diverter + SAPT
Enhet: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device

Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.
Eksperimentell: p64 MW strømningsavleder + DAPT
Enhet: Endovascular treatment of unruptured aneurysms with p64 MW HPC Flow Modulation Device

Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p64 MW HPC Flow Modulation Device.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of DWI lesions
Tidsramme: 48 hours (± 24 hours)

Number of diffusion-weighted imaging (DWI) lesions within 48 hours (+/- 24 hours) of the index procedure visualized via MRI.
48 hours (± 24 hours)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Short-term morbi-mortality rate
Tidsramme: 30 days (± 7 days)

Morbi-mortality rate at 30 days assessed by mRS > 2
30 days (± 7 days)
Rate of neurological death or major stroke
Tidsramme: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

Rate of neurological death or major stroke (ischemic or hemorrhagic, defined as an increase of 4 or more points according to the National Institute of Health Stroke Scale Score) in the territory supplied by the treated artery, as assessed by the Clinical Events Committee
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Long-term morbi-mortality rate
Tidsramme: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

Rate of subjects who have a mRS decline to a score of 3 or more (mRS > 3), or an increase of 2 points from baseline mRS score, as assessed by the Clinical Events Committee
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of subjects with dissusion-weighted imaging (DWI) lesions
Tidsramme: 48 hours (± 24 hours)

Rate of subjects with greater than 6 diffusion-weighted imaging (DWI) lesions or territorial stroke
48 hours (± 24 hours)
Delayed aneurysm rupture
Tidsramme: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

Rate of an intracranial hemorrhage from delayed aneurysm rupture (from the day after index procedure), as assessed by the Clinical Events Committee
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Delayed intraparenchymal hemorrhage
Tidsramme: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

Rate of delayed intraparenchymal haemorrhage unrelated to aneurysm rupture, as assessed by the Clinical Events Committee
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of peripheral bleeding
Tidsramme: Any event reported from discharge to 365 days (335 - 456 days) post procedure

Rate of peripheral bleeding, as assessed by the Clinical Events Committee
Any event reported from discharge to 365 days (335 - 456 days) post procedure
Rate of device deployment at the target site without technical complications
Tidsramme: During intervention

Rate of device deployment at the target site without technical complications, as assessed by the site
During intervention
Rate of complete aneurysm occlusion
Tidsramme: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

Rate of complete aneurysm occlusion using the 3-grade scale, as assessed by the Core Lab
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of target aneurysm recurrence
Tidsramme: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

Rate of target aneurysm recurrence, as assessed by the Imaging Core Lab
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of target aneurysm retreatment
Tidsramme: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

Rate of target aneurysm retreatment, as assessed by the Clinical Event Committee
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Rate of intrastent stenosis and/or thrombosis at the target site
Tidsramme: 180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure

Rate of intrastent stenosis and/or thrombosis at the target site, as assessed by the Core Lab through DSA
180 days (150 - 240 days) and 365 days (335 - 456 days) post procedure
Mean length of hospital stay
Tidsramme: From admission up to discharge, assessed up to 456 days

Mean length of hospital stay (from hospital admission and up to hospital discharge)
From admission up to discharge, assessed up to 456 days

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Phenox GmbH

Etterforskere

  • Hovedetterforsker: Laurent Pierot, Prof. Dr., CHRU Hôpital Maison-Blanche

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

3. september 2021

Primær fullføring (Faktiske)

4. desember 2024

Studiet fullført (Faktiske)

12. desember 2025

Datoer for studieregistrering

Først innsendt

26. april 2021

Først innsendt som oppfylte QC-kriteriene

30. april 2021

Først lagt ut (Faktiske)

3. mai 2021

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

18. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CO48/BO1309

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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